A Pilot Proof of Concept, Randomized Controlled, Single-Center Study of a Decision Aid Tool for Older Patients Considering LHC as Treatment for NSTEMI

NCT04270630 | Completed DMC

• 1 other identifier: 19-01687
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a single-center, prospective, un-blinded, randomized controlled trial evaluating a decision aid tool for older patients considering left heart catheterization (LHC) as treatment for non-ST elevation myocardial infarction (NSTEMI). The study population is 50 total inpatients (25 per study arm) with NSTEMI eligible for elective LHC. The first arm is the control group that will receive standard of care, while the second arm will have access to the decision aid and shared-decision making conversation with one of the co-investigators. Baseline characteristics and surveys/questionnaire data will be collected after study intervention (as applicable), and prior to final decision regarding LHC. Statistical analyses will be conducted on the primary endpoint, decisional conflict score, as well as on various secondary endpoints.

Conditions

NSTEMI

Keywords

Shared decision making; Left heart catheterization; Non-ST elevation myocardial infarction; Decisional conflict; Decision aid

Outcome Measures

Primary Outcomes (1)

• Percent change in mean decisional conflict score between the control and interventional group

  A reduction in decisional conflict score will be measured with the DCS tool to reflect an increase in the quality of the decision.

  Visit 1 (Day 0)

Secondary Outcomes (1)

• Descriptive Statistics in the use of the Patient Decision Aid

  Visit 1 (Day 0)

Study Arms (2)

Standard of care

NO INTERVENTION

Patients in the control arm of the study will undergo standard of care treatment, discussing catheterization with their treating physicians.

Shared decision aid

EXPERIMENTAL

Patients in the interventional arm of the study will discuss catheterization with their treating physicians, in addition to having access to the shared decision aid tool and a shared decision conversation with a co-investigator clinician.

Behavioral: Shared Decision Aid

Interventions

Shared Decision Aid BEHAVIORAL

The decision aid was developed by this study group based on the International Patient Decision Aid Standards Collaboration's minimum standards for quality, and the Ottawa Framework (a process by which patients' and clinicians' decision determinants are assessed, a decision aid is developed that is tailored to these needs, and the quality of the decision-making process with the aid is evaluated). The aid then underwent an iterative feedback process with a patient advisory panel. Adjustments to format, length, and readability were made. A final feedback session occurred with three patients over the age of 70, after which point the paper decision aid was digitalized. The intervention will be delivered in-person by one of the co-investigators of the study. The intervention will occur once, prior to the patient making a final decision regarding undergoing left heart catheterization as treatment for NSTEMI. The approximate duration of the intervention is 30 minutes.

Shared decision aid

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Must be admitted to the hospital, and there must be clinical suspicion for type I NSTEMI
• Must be eligible for non-urgent revascularization
• Must have capacity to consent for the study based on the judgment of the study investigators
• Must speak English

You may not qualify if:

• Has significant vision or hearing impairment that prohibits use of the decision aid
• Unable to read
• Has a clinical diagnosis of dementia and/or severe cognitive impairment documented in the electronic medical record

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• John Dodson, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: July 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to rachel.sibley@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)